The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0208-2019·Announced 2018-11-07

Pharm D Solutions Recalls Trimix T-106 Due to Sterility Concerns

Pharm D Solutions is recalling specific lots of Trimix T-106 aqueous solution because the company cannot ensure the product is sterile.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an injectable solution.

Plain-English summary

Pharm D Solutions, LLC is recalling specific lots of Trimix T-106 30PA-1PH-25A Aqueous Solution. The recall is being conducted because the company lacks assurance of the sterility of the product.

The affected product is a 44-milliliter aqueous solution with NDC 69699-1339-05. The recall covers two specific lots: Lot 03292018:66 with a discard by date of 9/24/2018, and Lot 05312018:81 with a discard by date of 11/27/2018. The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected lots and contact Pharm D Solutions, LLC or their healthcare provider for further instructions. The FDA has classified this recall as Class II.

The recalled product

Product
Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1339-05
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable Solution
Hazard
Affected units
44

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 03292018:66 Discard by: 9/24/2018
  • 05312018:81 Discard by: 11/27/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Pharm D Solutions, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 79 products in this recall →

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